Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

Malnutrition Clinical Trial

Official title:

Effect of Intradialytic Parenteral Nutrition on Morbidity and Mortality of Malnourished Hemodialysis Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00314834
• Other study ID #: EZUS-A1244
• Status: Terminated
• Phase: Phase 4
• First received: April 14, 2006
• Last updated: April 14, 2006
• Start date: January 2001
• Est. completion date: December 2004

Study information

• Verified date: March 2005
• Source: EZUS-LYON 1
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score

Description:

IDPN is widely used in HD patients without clue of its effectiveness. Study objectives: to evaluate IDPN effects on mortality (main objective), hospitalization rates, nutritional status, dialysis efficacy, Karnofsky score.

Patient eligibility: adult patients ≤ 82 y with HD vintage > 6 mo. and 2 of the following malnutrition criteria: BMI ≤ 20 kg/m2, BW loss/6 mo. ≥ 10%, serum albumin ≤ 35 g/L, prealbumin ≤ 300 mg/L.

Recruitment: patients in 38 HD units from January 2001 to December 2002 Study protocol. Patients are randomized into 2 groups: IDPN group, given IDPN during one year, and control group. For ethical reasons, the 2 groups are given oral supplementation during the same period.

Follow-up: two years after start of nutritional therapy. Study end: December 31, 2004. Final results will be available in early 2005.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 204
• Est. completion date: December 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 82 Years

Eligibility

Inclusion Criteria:

• age between 18 and 82 years

• hemodialysis vintage more than 6 months

• two of the following markers of malnutrition:

• body mass index (BMI) <= 20 kg/m2

• body weight loss within 6 months >= 10 percent

• serum albumin <= 35 g/L

• prealbumin <= 300 mg/L

Exclusion Criteria:

• weekly dialysis time < 12 h

• urea Kt/V index < 1.2

• serum albumin > 38 g/L

• prealbumin > 330 mg/L

• hypertriglyceridemia > 2.5 mmol/L

• associated comorbidities compromising the one-year survival

• treatment by oral, enteral or parenteral feeding during the last 3 months

• hospitalization at time of randomization

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hemodialysis
• Malnutrition

Intervention

Drug:
• Intradialytic parenteral nutrition

Locations

Country	Name	City	State
n/a

Sponsors (4)

Lead Sponsor	Collaborator
EZUS-LYON 1	Institut National de la Santé Et de la Recherche Médicale, France, Societe Francaise de Dialyse, Societe Francophone de Nutrition Enterale et Parenterale

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality
Secondary	hospitalization rate, Karnofsky score, BMI, serum albumin and prealbumin